Toric Alignment Marker, 3, 6, 9 O'Clock

FDA UDI

Class I (US FDA UDI)

by Blink Medical Limited

Identity

Trade Name: Toric Alignment Marker, 3, 6, 9 O'Clock FDA UDI
Generic Name: Scleral marker, single-use FDA UDI
Model / Reference: 91-6001 FDA UDI

Identifiers

Primary DI / UDI-DI: 05060480408265 FDA UDI
FDA Product Code: HMR FDA UDI
GMDN Term: Scleral marker, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Scleral marker, single-use

Toric Alignment Marker, 3, 6, 9 O'Clock by Blink Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Blink Medical Limited

Sources (1)

FDA UDI e614e2c6-08db-4140-b7b6-f35285058a10 32 fields · synced Jun 8, 2026